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NCT Number: NCT03625258

Mutations of the Pre-core Region of Hepatite B Virus (HBV)

Hepatitis B virus (HBV) infection constitutes a major public health threat worldwide. A total of 92 patients with HBeAg-negative chronic hepatitis B infection were recruited at Amiens University Hospital. The diagnostic workup included a physical examination.In conclusion, the study results confirmed that the HBV DNA level is associated with liver fibrosis status and that HBV viral load is strongly correlated with BCP and PC mutations, and it demonstrated that the impaired base pairing 1858-1896 mutations at the base of the bulge in the e encapsidation signal is independently associated with high serum HBV DNA levels.

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Key information

Conditions

Hepatitis B Virus Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens-Picardie

Amiens, 80054, France

About this study

The progression of liver disease in hepatitis B virus (HBV) infection is fostered by active virus replication. Mutations in the basal core promoter (BCP) and precore (PC) regions of the HBV genome are known to have an impact on viral replication. The aim of the present study was to assess the correlation of mutation profiles in the BCP and PC regions with the viral load in HBeAgnegative chronically infected patients. The HBV genotype, BCP/PC mutations, serum HBV DNA levels, and associated serological markers were analyzed in 92 HBeAgnegative chronically infected patients.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients included will be chronic carriers (HBsAg + for more than 6 months) of HBV, with detectable serum viral load greater than or equal to 100 IU / mL, included in the queue followed by Drs. Dominique Capron and Eric N'Guyen-Khac.

These patients will not be on anti-HBV treatment.

Exclusion criteria

  • Patients under 18 years old
  • Patients with their hepatitis B
  • Patients with HBV viral load undetectable or less than 100 IU / mL.
  • Immunosuppressive treatments such as corticosteroids or other
  • The co-infection with the hepatitis C and / or HIV virus
  • Patients with cancer

Treatment and study plan

Primary outcomes

  1. Genotype of HBV for which the HBV viral load is a function of pre-core mutations

    Time frame: 2-years

    The main objective of the study is toevaluate a genotype of HBV for which the HBV viral load is a function of pre-core mutations in chronically infected patients.The HBV markers (including HBsAg, HBeAg and anti- HBe) were measured with chemiluminescent microparticle immunoassays running on an Architect system.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

Influence of Mutations in the Pre-core Region of Heptatis B Virus (HBV) and Its Promoter on Serum VHB Viral Load in Chronically Infected Patients

Acronym: HEPATITEB

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Aug 10, 2018
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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